MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COCR FEMORAL HEAD; PROSTHESIS HIP

Catalog Number 00801803201

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Local Reaction (2035); No Information (3190); Metal Related Pathology (4530)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part # unknown / unknown taper / lot # unknown.Part #unknown / unknown cup/ lot # unknown.Part #unknown / unknown stem/ lot # unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-04206.

Event Description

It was reported patient underwent right hip revision approximately ten years and 3 months¿ post implantation for unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.D11: item#: 00771101000 / femoral stem 12/14 neck taper / lot#: 61312353.Item#: 00630505032 / liner / lot#: 61289809.Item#: 00620005222 / shell / lot#: 61292704.Item#; 00625006530 / bone screw / lot#: 61371953.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-00244.

Event Description

It was further reported from patient's medical records, that the patient underwent a hip revision for pain and adverse location tissue reaction (altr).During the revision, pseudocapsular tissue was debrided and taper corrosion was noted on the neck of the femoral stem.The head and liner were revised.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; g3; h2; h3; h4; h6 device history record (dhr) was reviewed and no discrepancies were found.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent a right total hip arthroplasty on due to osteoarthritis.Zimmer biomet components were implanted without complications.The patient was revised on due to failed hip arthroplasty.The patient presented with worsening pain, thigh mass with labs and imaging consistent with corrosion and altr.During the procedure, pseudotumor/pseudocapsule was debrided.There was black debris on the trunnion.Pathology report revealed fragments of necrotic tissue, and fibroadipose tissue with foreign body giant cell reaction and patchy mixed inflammation.The head and liner were replaced with new zimmer biomet products.No other findings related to the reported event were noted.Root cause was unable to be determined.The additional information received does not change the final conclusions of previous investigation.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- head.Visual examination of the returned product identified signs of being implanted worn / foreign material.The head was submitted for further analysis.Analysis determined this taper was assigned a modified goldberg score of 4.A score of 4 corresponds to ¿damage over the majority (>50%) of the surface with severe corrosion attack and abundant corrosion debris¿.Root cause remains unchanged.This complaint is confirmed based on the provided medical records and returned device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COCR FEMORAL HEAD
• Type of Device: PROSTHESIS HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11058470
• MDR Text Key: 223364602
• Report Number: 0001822565-2020-04205
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 00801803201
• Device Lot Number: 61350072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/29/2020; 01/08/2021; 04/27/2021; 08/14/2023
• Supplement Dates FDA Received: 12/30/2020; 01/27/2021; 05/01/2021; 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female